Cyclopentolate Hydrochloride

Indications

INDICATIONS AND USAGE Cyclopentolate hydrochloride ophthalmic solution is used to produce mydriasis and cycloplegia.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Adults: Instill one or two drops of 1% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 1% solution in the eye, which may be repeated five to ten minutes later by a second application of 1% solution if necessary. Individuals with heavily pigmented irides may require higher strengths.

Contraindications

CONTRAINDICATIONS Hypersensitive to any component of this preparation.

Warnings and precautions

WARNINGS FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION. This preparation may cause Central Nervous System (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger cyclopentolate hydrochloride solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 1 drop of a 1% cyclopentolate solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes following instillation.

Pregnancy

Pregnancy: Animal reproduction studies have not been conducted with cyclopentolate. It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered to a pregnant woman only if clearly needed.

Storage and supply

HOW SUPPLIED Cyclopentolate hydrochloride ophthalmic solution USP, 1% is available in multidose plastic squeeze bottles with a controlled drop tip and red cap in the following sizes: 2 mL bottle - NDC 24208-735-01 15 mL bottle - NDC 24208-735-06 Storage: Store between 15°C to 25°C (59°F to 77°F). KEEP OUT OF REACH OF CHILDREN.

Source: Cyclopentolate Hydrochloride (Cyclopentolate Hydrochloride) — US FDA prescribing information, 2022-09-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.